Sterilization; Overview Of Validated Procedures - Erbe 20192-094 Manual Del Usuario

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5.10 Sterilization

Only sterilize products that have been cleaned and disinfected.
Erbe Elektromedizin recommends steam sterilization with the
method described below. If other sterilization methods are used,
Erbe Elektromedizin shall bear no responsibility.
Steam sterilization
• Fractionated vacuum method with adequate product drying
• Holding time 3 to 18 minutes at 270 to 280 °F (132 to
138 °C)
• Sterilizers in accordance with applicable national standards
and regulations (e.g. ANSI/AAMI ST79:2010 & A1:2010)
• Sterilization process validated according to ANSI/AAMI/
ISO 17665
Please follow the recommendations issued by the sterilizer man-
ufacturer concerning loading, handling, etc.

5.11 Overview of Validated Procedures

The following procedures have been validated as suitable for
processing the product:
• Manual cleaning/disinfection with the detergent neodisher
mediclean forte (Dr. Weigert GmbH & Co. KG, Hamburg/Ger-
many) and disinfectant Cidex OPA (Johnson & Johnson Med-
ical Limited, Gargrave, Skipton).
– neodisher mediclean forte: Dosage ½ oz/gallon of warm
tap water, 5 minutes exposure time at room tempera-
ture.
– Cidex OPA: Minimum effective concentration (MEC)
0,3%, 12 minutes exposure time at 61-68 °F (16-20 °C).
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